EUCTR2008-000803-26-DE
Active, not recruiting
Not Applicable
A controlled randomized double-blind multi-center phase II study of FOLFOX6 or FOLFIRI combined with sorafenib versus placebo in second-line metastatic colorectal carcinoma - FOLFOX6/FOLFIRI plus Sorafenib in second-line Colorectal cancer (FOSCO)
DrugsNexavar
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AIO Studien gGmbH
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \> 18 years
- •2\. ECOG Performance Status of 0 to 2
- •3\. Life expectancy of at least 12 weeks
- •4\. Subjects with at least one uni\-dimensional (RECIST) measurable lesion of
- •metastatic colorectal carcinoma after first\-line chemotherapy with an
- •Oxaliplatin\- or Irinotecan based Fluoropyrimidine containing regimen ±
- •bevacizumab and had a progression subsequently. Lesions must be
- •measured by CT\-scan or MRI.
- •5\. Adequate bone marrow, liver and renal function as assessed by the following
- •laboratory requirements to be conducted within 7 days prior to screening
Exclusion Criteria
- •1\. History of cardiac disease: congestive heart failure \>NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti\-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
- •2\. History of HIV infection or chronic hepatitis B or C
- •3\. Active clinically serious infections (\> grade 2 NCI\-CTC version 3\.0\)
- •4\. Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry)
- •5\. Patients with seizure disorder requiring medication (such as steroids or anti\-epileptics)
- •6\. History of organ allograft
- •7\. Patients with evidence or history of bleeding diathesis
- •8\. Patients undergoing renal dialysis
- •9\. Known deficit in Dihydropyrimidine Deshydrogenase (DPD)
- •10\. Contraindications for the use of atropine in patients receiving FOLFIRI
Outcomes
Primary Outcomes
Not specified
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